MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION 16 LEAD; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2316-50E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Pain (1994)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

Model number/catalog number: sc-2316-50e, serial number: (b)(4), batch/lot number : 5054915, model/catalog description: infinion 16 trial lead kit 50 cm.

Event Description

A report was received that within a trial, the patient had an infection at the lead site.Symptoms of inflamed, redness and soreness were noted.It was also reported that the patient experienced abscess during hospitalization which caused difficulty walking.The patient was placed on antibiotics through peripherally inserted central catheter (picc) line and underwent a lead pull procedure.

Manufacturer Narrative

Additional information was received that the patient was naturally susceptible to getting infections, and that there was nothing that happened during the procedure that would cause infection.Model number/catalog number: sc-2316-50e, serial number: (b)(4), batch/lot number : 5054915, model/catalog description: infinion 16 trial lead kit 50 cm.A review of the manufacturing documentation for the ipg and lead revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices were found to be satisfactory.

Event Description

A report was received that within a trial, the patient had an infection at the lead site.Symptoms of inflamed, redness and soreness were noted.It was also reported that the patient experienced abscess during hospitalization which caused difficulty walking.The patient was placed on antibiotics through peripherally inserted central catheter (picc) line and underwent a lead pull procedure.

• Brand Name: INFINION 16 LEAD
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: talar tahmasian tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7632016
• MDR Text Key: 112132036
• Report Number: 3006630150-2018-60007
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2020
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 5054911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR